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Published online: 2025-02-17

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Effect of Short-Term Basal Insulin Initiation in Newly Diagnosed Type 2 Diabetes on One-Year Glycemic Control: Prospective Cohort, Interventional, Two-Arm Study

Duha Ayad Alidrisi1, Haider Ayad Alidrisi2, Ali Mohammed Hadi1

Abstract

Objective: To determine the efficacy and safety of early intensive insulin on treatment-naïve, newly diagnosed type 2 diabetes (T2D) patients over one year. Materials and methods: The study is a prospective cohort, interventional, 2-arm study. It included 243 newly diagnosed, treatment-naïve T2D adult participants who were divided into 2 treatment groups. Both groups (1 and 2) were treated with triple combination glucose-lowering medications for one year. Group 1
participants also were treated with insulin glargine U100 once daily for 2 weeks. The outcomes were glycated hemoglobin (HbA1c), bodyweight changes, and hypoglycemia over one year. Results: At 3-month evaluation, the achievement of HbA1c < 7% (53 mmol/mol) was 98/119 (82.4%) in group 1 and 61/124 (49.2%) in group 2, (p < 0.0001). At the 12-month evaluation, HbA1c <6.5% (48 mmol/mol) was achieved in 42/109 (38.5%) of group 1 and 27/114 (23.7%) of group 2, (p = 0.01). The 2 groups had significant bodyweight reduction compared to the baseline. The proportion of participants with hypoglycemia was 8.4% in group 1 and 2.4% in group 2. Conclusions: Two weeks of basal insulin in newly diagnosed T2D with severe hyperglycemia resulted in rapid, more effective, and maintained glycemic control at one-year follow-up. It was safe with less mild hypoglycemia and without weight gain.

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